1. Field of the Invention
The present invention relates to surgical devices and more particularly to a controlled release therapeutic device or system for the treatment of infants by a therapeutic device which includes dynamic structural means therein to controllably dispense a body treating material to the infant over a prolonged period of time by the slow release of body treating material.
2. Description of the Prior Art
Baclofen (Lioresal) is a drug that is widely used for patients with spasticity of muscles. Spasticity is a tightness or stiffness of muscles which typically results from a disorder or injury to the central nervous system. Presently, it is believed that damage to the brain or spinal cord may prevent certain nerve signals from reaching areas of the spinal cord that normally releases a substance; namely, gamma-aminobutyric acid (GABA). GABA is an amino acid which functions as an inhibitory calming neurotransmitter and plays a role in muscle relaxation. Baclofen is similar to GABA and functions as a muscle relaxant and antispastic. Typically, Baclofen is administered orally or intrathecally.
Intrathecal Baclofen therapy is a unique treatment for spasticity. The therapy delivers Baclofen directly into the fluid surrounding the spinal cord in small, precisely controlled doses using a pump that is implanted internally of the patient. If the drug is administered intrathecally, the pump is implanted in the abdomen of the patient and a catheter in the form of a long hollow plastic tube is inserted into the patient""s intrathecal space where the medication can be pumped directly into the spinal fluid by the pump. The Baclofen medication pump is about one-inch thick and measures three inches in width and weighs about six ounces.
After the pump and the catheter are implanted surgically into the patient""s abdomen, the surgeon uses an abdominal binder to decrease any possible surgical complications. The binder is used to prevent fluid retention around the pump, and decrease the possibility of the pump moving in the patient""s abdomen. The binder increases the stability of the Baclofen pump in the xe2x80x9cpump pocketxe2x80x9d of the patient.
After pump placement in infants and small children, the prior practice has been to employ adult-sized binders and alter them to fit the children. It has been found that these binders were uncomfortable. Children patients complained of discomfort, irritation at incisional sites, and that some binders were too warm. The children did not like wearing the altered adult binders and parents were not motivated to encourage the children to wear them.
The above problems led to the development of a pediatric abdominal binder containing the features of the present invention.
It is an object of the invention to produce a surgical device for use by infants to assist in maintaining a controlled release therapeutic device in the abdomen of a pediatric patient.
Another object of the invention is to produce a surgical device for use with pediatric patients to apply pressure to an operative site adjacent an implanted structural means to controllably dispense a body treating material.
The above objects may typically be achieved by producing an abdominal support for a pediatric patient comprising an elongate strip of elastic material having an extended surface and spaced apart ends of a length sufficient to surround the patient in the region of the abdomen of the patient; separable fasteners attached to the ends of the strip for accommodating patients of differing girths; and a cover disposed adjacent at least the extended surface of the strip adapted to lay against the abdomen of the patient.